Experience

Adverum Biotechnologies

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Director, Regulatory Affairs, Operations

  • Feb 2022 - Present



Treximo (A ProPharma Group Company)

• United States
• Business Consulting and Services
• 1 - 100 Employee

• Sr. Director, Regulatory Operations

  • Apr 2021 - Feb 2022



West Therapeutic Development, LLC

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director, Regulatory Affairs

  • Feb 2020 - Apr 2021



Melinta Therapeutics

• United States
• Biotechnology Research
• 100 - 200 Employee

• Director, Regulatory Operations

  • Apr 2015 - Feb 2020

  Regulate teams of four members overseeing the submissions for accuracy, publishing, and submission management. Cultivate business processes for quality assurance of published outputs for precision in formatting and navigational features. Head the Vault platform across the organization. • Aggressively negotiate contracts with vendors, Veeva and SPL. • Launch a RegOps team from conception through to formulation. • Streamline the implementation of a Veeva Platform including RIM… Show more Regulate teams of four members overseeing the submissions for accuracy, publishing, and submission management. Cultivate business processes for quality assurance of published outputs for precision in formatting and navigational features. Head the Vault platform across the organization. • Aggressively negotiate contracts with vendors, Veeva and SPL. • Launch a RegOps team from conception through to formulation. • Streamline the implementation of a Veeva Platform including RIM, Publishing, Quality Docs, and PromoMats. Veeva’s first customer for Vault Publishing, assisting Veeva with business processes for future customers. • Influential leader for the roll-out of Veeva Vault Submissions handling the assessment, test scripts, training material development, and training. • Manage timelines and documents for NDAs, PMCs/PMRs, Annual Reports and Monthly Investigator Updates • Work cross functionally with QA, CMC, Clinical and Marketing to streamline processes • Strategic lead for three products, including managing timelines and interfacing with FDA Show less Regulate teams of four members overseeing the submissions for accuracy, publishing, and submission management. Cultivate business processes for quality assurance of published outputs for precision in formatting and navigational features. Head the Vault platform across the organization. • Aggressively negotiate contracts with vendors, Veeva and SPL. • Launch a RegOps team from conception through to formulation. • Streamline the implementation of a Veeva Platform including RIM… Show more Regulate teams of four members overseeing the submissions for accuracy, publishing, and submission management. Cultivate business processes for quality assurance of published outputs for precision in formatting and navigational features. Head the Vault platform across the organization. • Aggressively negotiate contracts with vendors, Veeva and SPL. • Launch a RegOps team from conception through to formulation. • Streamline the implementation of a Veeva Platform including RIM, Publishing, Quality Docs, and PromoMats. Veeva’s first customer for Vault Publishing, assisting Veeva with business processes for future customers. • Influential leader for the roll-out of Veeva Vault Submissions handling the assessment, test scripts, training material development, and training. • Manage timelines and documents for NDAs, PMCs/PMRs, Annual Reports and Monthly Investigator Updates • Work cross functionally with QA, CMC, Clinical and Marketing to streamline processes • Strategic lead for three products, including managing timelines and interfacing with FDA Show less



Lundbeck

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manager, Regulatory Operations

  • Jul 2006 - Apr 2015

  As a professional with Lundbeck, I supported the cultivation of Workload Metrics, which modelled the throughput of submissions going through ESG Gateway. I established policies and procedures that facilitated Regulatory Operations, productivity, and efficiency for group work. I monitored the quality of QC Documents and collaborated with functional groups authors over document discrepancies. I held responsibility for the training and oversight of Regulatory Operations contractors within the U.S.… Show more As a professional with Lundbeck, I supported the cultivation of Workload Metrics, which modelled the throughput of submissions going through ESG Gateway. I established policies and procedures that facilitated Regulatory Operations, productivity, and efficiency for group work. I monitored the quality of QC Documents and collaborated with functional groups authors over document discrepancies. I held responsibility for the training and oversight of Regulatory Operations contractors within the U.S. business unit. I assembled and submitted required information for IND and NDA Annual Reports. I coordinated electronic assembly of documentation for numerous submission activities. The following are highlights of the value I have brought to the company: • Presided as a primary facilitator for the U.S. integration efforts into corporate policies and procedures within Lundbeck Regulatory Operations. • Executed cross-functional training on eCTD processes. Show less As a professional with Lundbeck, I supported the cultivation of Workload Metrics, which modelled the throughput of submissions going through ESG Gateway. I established policies and procedures that facilitated Regulatory Operations, productivity, and efficiency for group work. I monitored the quality of QC Documents and collaborated with functional groups authors over document discrepancies. I held responsibility for the training and oversight of Regulatory Operations contractors within the U.S.… Show more As a professional with Lundbeck, I supported the cultivation of Workload Metrics, which modelled the throughput of submissions going through ESG Gateway. I established policies and procedures that facilitated Regulatory Operations, productivity, and efficiency for group work. I monitored the quality of QC Documents and collaborated with functional groups authors over document discrepancies. I held responsibility for the training and oversight of Regulatory Operations contractors within the U.S. business unit. I assembled and submitted required information for IND and NDA Annual Reports. I coordinated electronic assembly of documentation for numerous submission activities. The following are highlights of the value I have brought to the company: • Presided as a primary facilitator for the U.S. integration efforts into corporate policies and procedures within Lundbeck Regulatory Operations. • Executed cross-functional training on eCTD processes. Show less



Abbott

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Regulatory Submission Publisher

  • Feb 2004 - Jul 2006



TAP Pharmaceuticals

• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Regulatory Affairs Associate

  • Aug 1998 - Feb 2004